Z-0761-2016 Class II Terminated
FDA device recall Z-0761-2016 was initiated by Del Medical, Inc. on December 3, 2015 and is designated Class II. Reason for recall: The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. The recall status is terminated (terminated January 26, 2018). Affected quantity: 4000.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2016
- Initiation Date
- December 3, 2015
- Termination Date
- January 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4000
Product Description
VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.
Reason for Recall
The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
Distribution Pattern
Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines.
Code Information
Product # Serial # 110-5010G1 , 00504-0214 110-5010G1 , 00855-0414 110-5010G1 , 00182-0114 110-5010G1 , 00108-0114 110-5010G1 , 00479-0214 110-5010G1 , 00014-0114 110-5010G1 , 00251-0214 110-5010G1 , 00854-0414 110-5010G1 , 00505-0214 110-5010G1 , 00342-0214 110-5010G1 , 00477-0214 110-5010G1 , 00184-0114 110-5010G1 , 00248-0214 110-5010G1 , 00588-0314 110-5010G1 , 00852-0414 110-5010G1 , 00107-0114 110-5010G1 , 00183-0114 110-5010G1 , 00480-0214 110-5010G1 , 00503-0214 110-5010G1 , 00443-0214 110-5010G1 , 00853-0414 110-5010G1 , 00941-0414 110-5010G1 , 00013-0114 110-5010G1 , 00343-0214 110-5010G1 , 00478-0214 110-5010G1 , 00249-0214 110-5010G1 , 00185-0114 110-5010G1 , 00442-0214 110-5010G1 , 00632-0314 110-5010G1 , 00475-0214 110-5010G1 , 00507-0214 110-5010G1 , 00015-0114 110-5010G1 , 00631-0314 110-5010G1 , 01008-0514 110-5010G1 , 00635-0314 110-5010G1 , 00011-0114 110-5010G1 , 00012-0114 110-5010G1 , 00345-0214 110-5010G1 , 00590-0314 110-5010G1 , 00440-0214 110-5010G1 , 00591-0314 110-5010G1 , 00506-0214 110-5010G1 , 00106-0114 110-5010G1 , 00774-0314 110-5010G1 , 00508-0214 110-5010G1 , 00476-0214 110-5010G1 , 00186-0114 110-5010G1 , 00587-0314 110-5010G1 , 00441-0214 110-5010G1 , 00589-0314 110-5010G1 , 00250-0214 110-5010G1 , 00247-0214 110-5010G1 , 00773-0314 110-5010G1 , 00344-0214 110-5010G3 , 01090-0514 110-5010G3 , 00709-0314 110-5010G3 , 00988-0414 110-5010G3 , 00010-0114 110-5010G4 , 01080-0514 110-5010G4 , 00047-0114 110-5010G4 , 00925-0414